Department of Health and Social Care

The Human Medicines Regulations 2012 Advisory Bodies – Annual Report 2017

lord o'shaughnessy: I have received the annual reports of the Human Medicines Regulations Advisory Bodies for 2017, which has been laid before Parliament today in accordance with the requirements of Part 2 Section 12 (4) of the Human Medicines Regulations 2012.I am glad to acknowledge the valuable work done by the distinguished members of the Human Medicines Regulations advisory bodies and thank them for the time and effort dedicated in the public interest to this important work. I attach a copy of the report.



Annual Report 2017
(PDF Document, 2.41 MB)





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Ministry of Defence

Call-Out Order to Support Operations in Mali

earl howe: My right hon. Friend the Minister of State for Armed Forces (Mark Lancaster) has made the following Written Ministerial Statement. A new call-out order has been made under section 56(1B) of the Reserve Forces Act 1996 to enable reservists to be called out into service to support operations in Mali. Currently, we plan on calling out only willing and available reservists who have the support of their employer. The order took effect from 18 May 2018 and ceases to have effect on 17 May 2019.

Department for International Trade

Comprehensive Economic and Trade Agreement

baroness fairhead: My Rt hon Friend the Secretary of State for International Trade and President of the Board of Trade (Dr Liam Fox MP) has today made the following statement.My Department has today laid the European Union (Definition of Treaties) (Canada Trade Agreement) Order 2017 to designate the EU-Canada Comprehensive Economic and Trade Agreement as a Treaty in accordance with the European Communities Act 1972. The European Union and Canada have concluded negotiation and signature of this Agreement, which was provisionally applied on 21 September 2017 and requires ratification by the EU Member States to come fully into effect. We have laid this Order which will be followed shortly by the laying of the text of the Agreement as a Command Paper under the Constitutional Reform and Governance Act for scrutiny. This is, in effect, the start of the formal process of ratification of the Agreement in the UK. This Agreement will boost the economies of the UK, Canada, and the EU, promoting bilateral trade and economic growth. It removed 98.2% of Canadian tariff lines with provisional application on 21 September 2017. This will rise to almost 99% over the next seven years. The Agreement also reduces non-tariff measures that businesses face when trading goods and services and when investing in Canada. The Government remains committed to supporting the EU’s ambitious trade agenda including the free trade agreements it is putting in place. We see UK ratification of CETA, whilst the UK is still an EU Member State, as a sound demonstration of this commitment. The Government has been clear that it will seek to ensure continuity in its existing EU trade agreements and other preferential arrangements as we leave the EU, including CETA. The Prime Minister and the Canadian Prime Minister have confirmed that both countries remain committed to a seamless transition of the trade preferences between the UK and Canada brought into effect with this Agreement. We have also laid before the House an Explanatory Memorandum to this Order. This explains the background and rationale of the Agreement and ratification. At the same time, we are publishing our economic impact assessment of this Agreement and the external study on which it is based. Copies of these documents are being placed in the Libraries of both Houses.  


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Department for Work and Pensions

Jobseeker’s Allowance trial

baroness buscombe: My honourable Friend the Minister of State for Employment (Alok Sharma MP) has made the following Written Statement.It has been a long-standing policy of successive Governments that claimants on work-related benefits are generally expected to undertake certain activities in return for financial support through the benefit system. This system of ‘conditionality’ can lead to sanctions, which deduct benefit from claimants when they fail, without good reason, to meet a conditionality requirement, such as failing to attend a Jobcentre interview or failing to search for work. This ensures a fair, proportionate and effective use of public money, in support of employment and wider outcomes for society.Today, we are publishing the Jobseeker’s Allowance (JSA) Sanctions Early Warning Trial’s final evaluation report (Jobseeker’s Allowance Sanctions Early Warning Trial Evaluation – Final report) and qualitative research (Jobseekers Allowance: Sanctions Early Warning Trial).In October 2015, the Department for Work and Pensions announced that it would be trialling a new process for JSA sanctions in response to the Work and Pensions Select Committee’s recommendations to review the JSA sanction process.The trial was delivered between April and September 2016 and involved 6,500 claimants. It tested an approach of adding an additional step into the sanction decision making process, by informing claimants through a ‘Sanction Warning Letter’ that, on the basis of information available, the Decision Maker intended to apply a sanction. Claimants were then given a further 14 days (on top of the standard 7 days they already receive before the decision is initially considered) to submit evidence of good reason for not meeting their conditionality.The aim of the trial was to consider whether such an approach would have an effect on:The volume of claimants that provide reasons for not meeting their conditionality requirements.The volume of claimants sanctioned who request a Mandatory Reconsideration of the initial sanction decision.The service received by the claimant and whether this represented value for money.The effectiveness of the process as perceived by Decision Makers.The key findings of the trial were:13 per cent of those receiving a ‘Sanction Warning Letter’ responded to it during the additional 14 days and provided evidence. In around half of these cases the evidence provided did not contain a good reason for the Labour Market Decision Maker to change their decision and the sanction was applied.There were some indications that the trial had an impact on reducing the proportion of cases where a Decision Review or Mandatory Reconsideration was carried out. However, as these findings are based on low volumes, they are indicative only.The qualitative evaluation concluded that given the additional burden placed on the Departmental resources and marginal gains achieved, the trial did not appear to be an effective use of the Department’s resource.Results from the qualitative evaluation showed that there was support from staff for the intentions underpinning the trial, however evidence from interviews with staff suggested that in practice the trial appeared to make little difference to the outcomes of claimants. Given the low proportion of cases in which claimants provided further evidence and the even lower proportion of cases where decision outcomes were changed, we do not consider that the benefits of the approach are sufficient to justify the extra time and cost it adds to the process.We are now exploring the feasibility of an alternative process to give claimants written warnings, instead of a sanction, for a first sanctionable failure to attend a Work-Search Review. The aim will be to conduct a small-scale proof of concept to obtain qualitative feedback from staff on this new process, followed by any subsequent tests. More details will be made available once we have progressed with the design work.


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Department for Digital, Culture, Media and Sport

Pre-Council WMS: Education, Youth, Culture and Sport Council

lord ashton of hyde: My Right Honourable Friend the Secretary of State for Digital, Culture, Media and Sport (Rt Hon Matthew Hancock) has made the following Written Statement:The Education, Youth, Culture and Sport (EYCS) Council will take place in Brussels on 22 and 23 May 2018. Lord Ashton of Hyde will represent the UK at the Youth session of this Council (on 22 May). The UK’s Deputy Permanent Representative to the EU will represent the UK on 23 May for the meetings on Culture & Audiovisual and Sport.YouthThis session of the Council will begin with the adoption of Council conclusions on the role of young people in building a secure, cohesive and harmonious society in Europe. The Council will then seek to adopt Council conclusions on the role of youth in addressing the demographic challenges within the European Union.Also tabled for this session is a policy debate on the future priorities for EU Youth policy.In addition, there will be information from the Commission on European Youth Together, followed by information from the Belgian and French delegations on the Franco-Belgian declaration of Ministers responsible for youth on the prevention of violent radicalisation.Culture/AudiovisualThis meeting will begin with the adoption of Council conclusions on the need to bring cultural heritage to the fore across policies in the EU.There will be also be a policy debate on the long term vision for the contribution of culture to the EU after 2020, in particular looking forward to the next Multiannual Financial Framework (2021-2027).Additionally, there will be a public deliberation of current legislative proposals. For this, the Council will first welcome information from the German delegation on the Directive amending Directive (2006/112/EC) as regards rates of value added tax - actively engaging in negotiations from a cultural policy perspective. In extension to this, there will be information from the French delegation on the regulation on the Import of cultural goods. No legislative decisions will be made in these debates, so there are no implications for the parliamentary scrutiny reservation.Information will be provided by the Lithuanian and Luxembourg delegations, on their respective hosting of the European Capitals of Culture 2022.SportThe sport session of EYCS will begin with the adoption of Council conclusions on promoting the common values of the EU through Sport. This will be followed by a policy debate on the commercialisation of elite sports and the sustainability of the European Model of Sport.The EU Member States representative in the World Anti-Doping Agency Foundation Board, will present information on the Foundation Board meeting on 16-17 May. The French delegation will present information on the informal meeting of the EU Minister for Sport (Paris, 31 May 2018) signing of a declaration for a Europe of Sport on the horizon of the 2024 Paris Olympic and Paralympic Games.OtherThere will be information from the Austrian delegation, setting out their work programmes as the incoming Presidency, for the second half of 2018.

Department for Transport

Road Haulage Update

baroness sugg: My Honourable Friend, the Parliamentary Under Secretary of State for Transport (Jesse Norman), has made the following Ministerial Statement.The Department for Transport is today updating the house on our work to improve on the current Operation Stack arrangements and ensure that traffic can keep flowing on the M20 even in the event of serious disruption to cross-Channel transport. At the same time, we are announcing a package of measures to tackle the blight of fly-parking across the south-east and other parts of the country, including plans to increase overnight lorry parking capacity which could potentially add an additional 1,500 spaces. Further to the Secretary of State’s statement of 15 November 2017, Highways England will soon be starting the consultation process on a permanent solution for holding lorries in the event of cross-Channel disruption, with a full public information exercise launching in June. The consultation will consider the broad solutions rather than specific sites. It will also seek views on the potential use of any future lorry park or parks for ‘business as usual’ overnight lorry parking; while remaining sensitive to the Government’s desire not to deter any planned private investment. In his November announcement, the Secretary of State also asked Highways England to develop an improved interim arrangement for holding lorries on the M20, whilst allowing traffic to continue to flow in both directions and keeping junctions open. The Department has now agreed with Highways England that this arrangement should take the form of a contraflow system which would see lorries for the Port of Dover and Eurotunnel held on the coast-bound carriageway between junctions 8-9 of the M20, while other traffic will use a contraflow to continue their journey on the other side of the motorway. Highways England are starting the preparatory works for the scheme now and it will be available from early 2019. As well as improving the contingency arrangements as to lorry parking, the Government is also focused on improving the situation for business-as-usual lorry parking. We have published the results of an in-depth survey carried out on the national picture of overnight lorry parking in England. The detailed information in the report will help local planning authorities to understand the nature of the issue better, at both a regional and local level. However, it is important to note that developers are already responding to what is currently a mismatch between supply and demand. There are planning applications in the pipeline which it is estimated would, if delivered, equate to over 1,000 additional spaces across the country. Given the evident need for further parking spaces, the Government will be taking three steps on its side: First, Highways England have begun to analyse their landholdings in order to identify sites with the potential to be developed into lorry parks. Initial work suggests that this might facilitate a total of around 1,500 additional parking spaces nationwide. Detailed feasibility work will be undertaken in the next six months. More generally, Highways England intend in future to give increased priority to the provision of lorry parking across the Strategic Road Network. Its initial report for the second Road Investment Strategy period (2020-2025) Highways England propose funding to support the provision of better roadside facilities, which would include lorry parking. The Department has consulted on this proposal and is carefully considering the responses received. Secondly, I have written with Planning Minister Dominic Raab to local planning authorities to draw their attention to the survey results, which show a strategic national need for more lorry parking and highlight shortages in specific areas. In addition, I am asking Highways England to develop their existing role as a statutory consultee on all proposed developments that are on or that directly affect the strategic road network. In future, Highways England will seek to use their unique network-wide perspective to assist local authorities in actively identifying areas of lorry parking need and potential solutions, including in the context of specific planning applications where these might help alleviate the situation. Thirdly, the Department will consider further steps to make it easier for local authorities to take enforcement action against hauliers who park inappropriately. In Kent the trial on a stretch of the A20 of innovative enforcement approaches has had considerable success in its first six months of operation, with a significant fall in the number of vehicles parked overnight, and increased use of commercial parking facilities in the area, especially at weekends. Subject to the findings of this 18-month trial, we will be looking to promote the wider application of such measures elsewhere. 


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Department for Exiting the European Union

Publication of the Framework for the UK-EU Security Partnership, 09/05/2018

lord callanan: The Secretary of State for Exiting the European Union, the Rt Hon David Davis MP, has made the following written statement:On Wednesday 9 May, we published the Framework for the discussions with the EU on the UK and EU’s future security partnership. These slides have been produced by the UK negotiating team for discussion with the EU, in order to inform the development of the future framework. This framework will set out the terms of our future relationship and will be concluded alongside the Withdrawal Agreement later this year.The United Kingdom wants to build a new, deep and special partnership with the European Union, enabling us to protect our shared interests and ensure we act together for our mutual benefit. The threats we face do not recognise the borders of individual nations. The Security Partnership we are seeking with the EU builds on the breadth and depth of our shared interests and values, and goes beyond any existing third country arrangements.Copies of these slides will be deposited in the libraries of both Houses. 


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Foreign and Commonwealth Office

Provision of Early Recovery Assistance to the Overseas Territories

lord ahmad of wimbledon: My Right Honourable Friend, the Secretary of State for Foreign and Commonwealth Affairs (Boris Johnson), has made the following written Ministerial statement:The United Kingdom is strongly committed to supporting the recovery of the British Overseas Territories of Anguilla, the British Virgin Islands and the Turks and Caicos Islands following the devastation caused by Hurricanes Irma and Maria last September. Through the Conflict, Stability and Security Fund we committed £72 million to support the immediate needs of the affected Territories from September 2017, of which £15m was approved on top of the initial commitment of £57m to support early recovery needs. This allocation was first brought to Parliament’s attention in the written ministerial statement made on 14 December 2017 (HCWS355) following the Joint Ministerial Council on Tuesday 28 and Wednesday 29 November. This funding, supplemented by Foreign and Commonwealth Office programme funds, supported Overseas Territory Governments in meeting their immediate needs.The Overseas Territories Directorate has led on dispursing this funding in consultation with Overseas Territory Governments, to achieve the following early recovery deliverables each worth over £100,000:Anguilla1) Repairs to educational infrastructure in Anguilla, with a value of up to £344,000 for phase 1, ensuring there is sufficient space for examinations, language tuition and theatre productions. This work is still ongoing.2) Orders worth £1,170,000 that provided Anguilla with a temporary air traffic control tower, fencing and ground lighting which contributed to the recertification of the territory’s airport. 3) Reimbursement to the Government of Anguilla for £2,740,000 of invoices for island-wide waste cleanup, interim infrastructure repairs and generator/electrical works for school buildings, and buildings costs on the Anguilla Fire and Rescue Services Building.4) Repairs and safety equipment for Her Majesty’s Prison, totalling £211,000.British Virgin Islands5) Promotion of employment in the construction sector in the British Virgin Islands, worth £363,000. This project is supporting the reform of the labour market and laws, as well as vocational training (construction and maritime) to prepare for the recovery and to promote more resilient building practises.6) Immediate repairs to housing for vulnerable families with inadequate insurance coverage, worth at least £1,260,000 This project is working with the British Virgin Islands Government plan to repair 70-100 homes and provide technical advice to use the repairs to spearhead the BVIG US$15m housing recovery programme. .7) A temporary magistrate’s court, worth up to £320,000. This will provide a secure premises for tackling the backlog of criminal cases, increasing public confidence in visible and effective rule of law while longer term criminal justice infrastructure is addressed. 8) Ongoing prison infrastructure repairs worth up to £676,000 to restore perimeter and internal fencing, roofing and locking systems, so that prisoners and staff have secure and decent living and working conditions. 9) The repair of 7 reservoirs on the British Virgin Islands, worth up to £1m that will restore the potable water network and enable basic water access for the majority of the population. 10) Repairs to the sewage and waterworks infrastructure and the procurement of maintenance vehicles to prevent it falling back into a state of disrepair, worth up to £1.1m. 11) The deployment of UK police personnel at a cost of £1,008,000 to provide surge support for law enforcement and support the Royal Virgin Islands Police Force to sustain public order.12) A programme of further support to meet the immediate capacity building needs of the Royal Virgin Islands Police Force, currently worth £1,349,000 with plans for continuation of training and leadership development support during the coming year.Turks and Caicos Islands13) Ongoing and planned prison infrastructure repairs worth up to £580,000 to repair perimeter lighting and install internal zonal fencing, improving movement and management of prisoners, and enabling the temporary restricted regime in place since the hurricanes to be lifted. 14) Restoration of the Radar system on the Turks and Caicos Islands, worth up to £350,000, enhancing border control and contributing to the security required for long-term recovery.Cross-Territory Support15) An order worth £5,296,000 that supported the electricity authorities in Anguilla and the British Virgin Islands to restore power to both territories.16) Orders worth £522,000 to provide uniforms and equipment for the police forces in all three affected territories17) The deployment of security personnel to TCI, BVI and Anguilla to fill staffing and capability gaps and support prison leadership and management. Support delivered in TCI up to the end of March 2018 (at a value of £475,000) has been extended (at a further cost of £119,000) to ensure basic safety, security and leadership development while repair work proceeds and TCI Government recruits additional staff. Additional personnel support to Anguilla from the same organisation (£217,000) has provided enhanced leadership planning and capability following the impact of the hurricanes. Support to BVI at a value of £194,000 has provided interim support until the arrival of the Scottish Prison Service in April 2018 to assist with enhanced security and management measures. 18) The provision of technical assistance and advisory support on recovery worth £547,00019) An order worth up to £1.2m to provide equipment for the tackling of the spread of vector borne diseases across the affected OTs, which will be funded from the FY 2018-19 OT CSSF programme.The provision of this assistance was in line with the Government’s hurricane recovery objectives for the Overseas Territories. Foreign and Commonwealth Office officials, along with UK Government advisors oversaw the procurement and delivery process. Where applicable, Memoranda of Understanding have been agreed with the Anguilla, Turks and Caicos Islands and British Virgin Islands Governments to cover their responsibilities once ownership has been transferred.In November 2017 the Prime Minister confirmed a further £70 million package of recovery and reconstruction support. £10m of this has been allocated to the British Virgin Islands and £60m to Anguilla. In the British Virgin Islands it will be supplemented by up to £300 million of UK loan guarantees. The British Virgin Islands House of Assembly has passed legislation to establish a Recovery and Development Agency that will take this programme forward.In Anguilla funds have been released for 6 priority projects, which the Government of Anguilla has estimated at approximately £10m. The release of further funding by UK Ministers is conditional on agreement of a Medium Term Economic and Fiscal Reform Plan to put Anguilla’s public finances on a stable footing for the long term. 


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